Director, Regulatory Information Systems (RIMS)
The Director of Regulatory Information Management drives how the regulatory function brings together technology, processes and resources to enable strategic objectives and underpin Regulatory core capabilities. Develops and implements the Regulatory Information Strategy in line with broader organization objectives. This role leads the oversight and governance of Regulatory systems, business processes and compliant usage to ensure that the objectives of the regulatory information strategy are met. The Director of RIM will partner with individual system owners within Regulatory to ensure the overall strategy for RIM is met. This role will provide the holistic strategy of Regulatory Systems integration, and partner with IT & Business functions as well as with vendor(s) to influence HA and industry innovation.
- Responsible for analysing Regulatory IT/technology industry trends and driving best practices across Regulatory and cross functional interfaces.
- Responsible for developing & evolving the regulatory information strategy in line with regulatory affairs & affected stakeholders, including industry and Health Authority perspectives, to ensure robust future proof processes and systems.
- Oversees new system implementation for the Regulatory function and partners with cross functional groups as applicable
- Accountable for overseeing regulatory information quality, reporting and analytics to monitor quality and maximize the use of regulatory information. Includes interface data that is required between different cross functional systems and drives the integration of data and processes
- Responsible for developing and implementing a strategy to ensure oversight of system compliance, business value and efficiency in the management and delivery of regulatory information services, leveraging appropriate vendor partnerships.
- Represent Vertex at HA/Industry body meetings for regulatory information strategy and influence applicable policies and adoptions of data standards and regulatory technological advancements
- Researches forthcoming regulatory guidance revisions and analyses subsequent impacts to internal processes & technology (e.g. IDMP/MDM). Communicates impacts to wider business functions, and drives execution in collaboration with stakeholders.
- Effectively communicates project status, issues, schedule and accomplishments to regulatory affairs and stakeholder groups, as needed. Ensures regulatory information strategy is communicated and understood by broader cross functional teams.
- Manage team with various levels of experience to ensure both company goals and individual growth opportunities are met
- Proactively make changes to team assignments as needed to support changing priorities
- Manage vendor relationship, as needed, related to regulatory operations activities
- Support compliance with worldwide submission regulations and guidelines by maintaining awareness and continually expanding knowledge of pertinent laws, regulations, guidance and practices.
- BA/BS degree or equivalent experience
- 10+ years of Regulatory Operations/Affairs experience
- Leadership experience in implementing innovative regulatory systems
- Leadership role in Regulatory information management/GxP data
- Highly developed Stakeholder Management skills
- Highly skilled in change management practices
- Experience managing personnel (internal FTEs or vendor management)
- Demonstrated skills managing project timelines and organizing resources
- Strong attention to detail and the ability to manage complex, multiple projects
- Fostering understanding and commitment to a regulatory information strategy involves not only multiple stakeholders, but many diverse systems and processes – driving this will require exception communication and influencing skills throughout all levels of the organization
- Working in high pressure environments and teams where sensitivity to their priorities needs to be carefully handled whilst still delivering against strategic objectives
- Excellent analytical skills
Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious and life-threatening diseases. We discovered and developed the first medicines to treat the underlying cause of cystic fibrosis (CF), a rare, life-threatening genetic disease. In addition to clinical development programs in CF, Vertex has more than a dozen ongoing research programs focused on the underlying mechanisms of other serious diseases. Founded in 1989 in Cambridge, Mass., Vertex today has research and development sites and offices around the world. For several consecutive years, Science magazine has named Vertex one of its Top Employers in the life sciences. For additional information and the latest updates from the Company, please visit www.vrtx.com. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.